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Clinical Trial Associate - Switzerland  

Company managed [?] Still accepting applications

Posted on : 14 May 2017

Project Description

Description:
  • Our company  is a  global biopharmaceutical group including five companies active in the life science areas of drug development, GMP manufacturing of proprietary drugs, diagnostic tools and investment management. 
  • Our company  is focused on the development of prescription drugs that target unmet medical needs. 
  • The company in-licenses and develops promising drug candidates. 
  • The products are commercialized by pharmaceutical out-licensing partners to give access to the largest number of patients worldwide. 
  • For our Clinical Research & Development Department , we are looking for a Clinical Trial Associate(12-month contract)

 
Your main responsibilities 
  • Support Clinical Trial Managers in daily operational activities related to clinical trials with external vendors (CRO) and internal stakeholders;
  • Generate, finalize and distribute study team agenda and meeting minutes in a timely manner. Act as a support to the CTM for meeting preparation;
  • Collect, verify and upload documents into eRoom (Sharepoint) under the responsibility of the CTM. 
  • Ensure a clear and consistent structure and filing method;
  • File and archive all study documents on the eTMF platform under the responsibility of the CTM and ensure inspection readiness of the TMF;
  • Follow up of study budget, preparation and update of purchase orders including management of study invoices;
  • Update and/or track study reporting tools (e.g. weekly follow-up chart, Export of the CRO reporting tool, CTMS);
  • Participate in clinical operations initiatives to reach increased quality, productivity and study management efficiency;
  • Depending on studies:
    • Create and distribute documents for study sites such as study binders;
    • Prepare regulatory files for submission to Health Authorities and Ethics Committees;
  • Contribute to transversal activities such as ClinicalTrials.gov registrations, clinical trial insurances, etc.
 


Your profile 
  • University/College degree level or equivalent in a relevant discipline.
  • Proven track record of 3-5 years of experience as CTA or comparable operating experience in Pharma/CRO/healthcare with good knowledge of budget and invoicing requirement, as well as drug development process and medical terminology.
  • Experience in Management and filing of Trial Master File content (Veeva Vault experience is a plus)
  • Excellent spoken and written English and French.
  • Customer orientation and Team spirit, with ability to foster a collaborative team environment in a fast paced matrix organization;
  • Ability to communicate with cross-functional teams.
  • Strong organizational skills with ability to manage stress, pressure and deadlines.
  • Good to advanced computer skills with requirement of MS applications. 



Offer:
  • An international and highly dynamic environment.
  • The opportunity to join a successful company, at the forefront of the most advanced scientific developments in the industry.
  • The possibility to be in a company in which innovation, people and entrepreneurship are the fundamentals of its success